Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04414956
Eligibility Criteria:
Inclusion Criteria:
* Patients with liver cirrhosis meeting one of the followings:
i. Histologically confirmed liver cirrhosis ii. Imaging findings with liver cirrhosis (liver surface undulation, irregularity, or nodularity by US, CT, or MRI) plus one of followings: liver stiffness measurement ≥ 12.5 kilopascal, esophago-gastric varices, thrombocytopenia (\<120,000/mm3), hypoalbuminemia (\<3.5 g/dL), splenomegaly ≥12 cm) iii. Imaging findings with liver cirrhosis together with biomarkers suggesting liver cirrhosis (APRI ≥2.0 or fibrosis-4 ≥3.6) iv. Imaging findings with liver cirrhosis with history of hepatic decompensation (ascites, esophago-gastric variceal bleeding, jaundice, hepatic encephalopathy))
* Expected survival more than 1 year
* Child Pugh score 5-10 at the time of enrollment
* Serum creatinine ≤1.5mg/dL
* Age between 19 and 75 years old
* No significant underlying medical illness affecting patient's survival
* Patients available for regular follow-up according to the study protocol
Exclusion Criteria:
* History of HCC
* AFP \>20 ng/mL
* Hepatic nodule ≥ 1 cm by US or CT Exceptionally, nodules showing characteristic features of benign lesion such as hemangioma or pathologically conformed benign lesion are permitted for study inclusion.
* Hepatic nodule less than 1 cm on US but imaging findings suggesting HCC by contrast enhanced US, CT, or MRI
* Child-Pugh score ≥ 11
* History of liver transplantation
* Expecting liver transplantation within 1 year
* Hypersensitivity on CT contrast dye
* Any contraindication for CT
* Not able to perform abdominal US
* Other uncontrolled malignancy
* Patients taking warfarin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT04414956
Study Brief:
Protocol Section:
NCT04414956